A 3D Analysis of Mandibular Plating Strategies in Oromandibular Reconstruction.

NCT03550053 | Completed

• 1 other identifier: 16-5984
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Reconstruction of the mandible commonly employs the use of metal plates to provide a framework for placement of bone grafts. The standard approach to reconstruction involves bending these plates to the mandible intraoperatively. A novel technique involves bending plates to three dimensional (3D) printed models of the mandible prior to surgery. No study has performed a quantitative analysis and comparison of these two different strategies. The purpose of this study is to compare reconstructive plating strategies (preoperative versus intraoperative bending) for mandibular reconstruction using 3D quantitative analysis. Preoperative diagnostic CT scans of the head/neck of 20 patients scheduled to undergo mandibular reconstruction will be obtained and imported into 3D modeling software. A computer based 3D reconstructed mandible will be printed. Simulated reconstruction will be replicated by contouring mandibular reconstruction plates to each model. The plates will be marked, sterilized and brought to the operating room on the day of surgery. Each patient will be randomized to either preoperative (n=10) or intraoperative (n=10) plate bending groups. The group will be revealed to the primary surgeon on the day of surgery and the patient will either be fit with the plate bent preoperatively or will undergo fitting with a plate bent intraoperatively. Following reconstruction of the mandible, the patient will undergo intraoperative cone beam scanning. Using scans performed pre- and post-mandibular reconstruction, the 3D simulated mandibles will be compared based on the position of the mandibular condyle within the Temporomandibular Joint. In addition, the percentage of surface area contact between the plate and mandible and the postoperative occlusion attained will be determined and compared between groups. It is expected that the preformed plates will have improved contact surface area, and better achieve pre-reconstruction occlusion when compared to plates bent intraoperatively.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Jaw contour

  Contour of the mandible will be measured using the pre and post-op CT images. A comparison will be made between the sets of images to determine which strategy of reconstruction (pre-bent plate or intraoperative bent plate) better recreates the native contours of the mandible.

  1 week after surgery

Secondary Outcomes (1)

• Change in Jaw occlusion

  1 week after surgery

Study Arms (2)

Intraoperative plate bending

ACTIVE COMPARATOR

Plate will be bent intraoperatively, which is the standard of care, for this surgery

Device: 3D mandibular plate

Preoperative plate bending

ACTIVE COMPARATOR

A 3D printed model of the patient's mandible will be used to bend the plate preoperatively by the surgeon. The pre-bent plate will be brought into the operating room on the day of surgery.

Device: 3D mandibular plate

Interventions

3D mandibular plate DEVICE

Patients will be randomly assigned to either have the mandibular plate bent before their surgery, using a 3D model of their mandible or have the mandibular plate bent during their surgery, which is standard of care.

Intraoperative plate bending; Preoperative plate bending

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing planned resection with osseous free flap reconstruction of the mandible
• Pathology limited to unilateral involvement of the mandible from the angle to the mandibular symphysis (lateral defects)

You may not qualify if:

• Patients under age 18
• Prior reconstruction of the mandible

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient will not know which group they are randomized to.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with head and neck cancer, specifically requiring surgery to their mandible.

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: June 8, 2018
• Study Start: March 16, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

CA (1)